Int J Clin Pharm Th
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Int J Clin Pharm Th · Jan 2010
Controlled Clinical TrialPopulation pharmacokinetic study of methotrexate in children with acute lymphoblastic leukemia.
A population pharmacokinetic model was developed to describe the factors that may affect the pharmacokinetics of methotrexate (MTX) in Chinese child patients with acute lymphoid leukemia (ALL) and to predict the individual pharmacokinetic parameters in these patients. One hundred and eighteen children with ALL who received MTX at the dose of 2 - 3.5 g/m(2) were enrolled in this study. 96 children were enrolled in the index group and 22 children in the validation group. The data were analyzed using nonlinear mixed effect model (NONMEM) software. ⋯ Moreover, some secondary pharmacokinetic parameters were estimated: the elimination half-life t1/2 was 2.34 h (CV = 36.7%), elimination constant k(e) was 0.33 h(-1) (CV = 33.2%), and the area under plasma concentration versus time curve AUC was 582.92 mg x h x l(-1) (CV = 55.9%). Our model combine Bayesian approach enabled a satisfactory estimation of MTX concentration in individual patients. The results of this study allowed clinicians to assess the MTX pharmacokinetic parameters based on the specific demographic characteristics of patients.